DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Generic: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

ANI PharmaceuticalsManufacturer
ORALRoute
DIPHENOXYLATE HYDROCHLORIDEActive Substance
1979-10-29Original Approval

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE is FDA application ANDA086727, sponsored by ANI PHARMS. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class I2017-10-20
diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1),

SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent

Top Reported Reactions

1
DRUG INEFFECTIVE
93 reports
2
MACULAR DEGENERATION
60 reports
3
NAUSEA
53 reports
4
OFF LABEL USE
42 reports
5
WEIGHT DECREASED
41 reports
6
PAIN
40 reports
7
MALAISE
33 reports
8
ABDOMINAL PAIN
32 reports
9
DIARRHOEA
32 reports
10
PYREXIA
32 reports